Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;

FDA Recall Z-0453-2012 · Posted 2012-01-11

Recalling FirmCepheid
Recall StatusTerminated
Product CodeNQX
Date Initiated2011-11-17
Date Terminated2012-01-09
Product Quantity1289

Reason for Recall

Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.

Firm Action

On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Product was released for distribution in US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101879XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10Cepheid · 2010-07-28K082140XPERT MRSA/SA BLOOD CULTURE ASSAYCepheid · 2008-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑